Designing multimedia patient education materials for adolescent idiopathic scoliosis: A protocol for a feasibility randomized controlled trial of patient education videos

Baseline assessment Following informed consent, participants will electronically complete a series of baseline assessments of demographics and outcome measures, with the primary author being available by phone or electronically if assistance is required. A description of the baseline variables plus other study outcomes and their purpose is shown in Table 1. Randomization & masking Upon consenting to participate in the study, participants will be randomized by a random number generator on a 1:1:1 ratio into one of the three intervention arms by a member of the research team who will be masked to the interventions and follow-up assessment of outcomes. Participants will be told that the trial will compare usual care with two other multimedia video interventions. Participants in the usual care group will not be masked to their allocation but the participants in the two video interventions will not be aware of their allocation to videos with traditional format or augmented format. Table 1. Baseline and outcome variables collected and their purpose, with the primary feasibility outcomes in bold. Variable Measure Time points (weeks) Purpose & dimension of RE-AIM framework Age Date of birth 0 Describe population, reach Gender Male/female 0 Describe population, reach Date of plain film radiographs confirming scoliosis Weeks 0 Describe population, reach Date of last radiograph Weeks 0 Describe population, reach Duration since care-seeking Weeks 0 Describe population, reach Major Cobb Angle Degrees 0 Describe population

Minor Cobb Angle (if applicable) Degrees 0 Describe population Brace treatment Yes/No 0 Describe population Surgical treatment Yes/No 0 Describe population Physiotherapy treatment Yes/No 0 Describe population Quality of life SRS-22 0, 8 Secondary outcome EQ-5D-Y 0, 8 Secondary outcome Physical Activity PAQ-C 0, 8 Secondary outcome Anxiety STAI-Ch 0, 8 Secondary outcome Immediate Knowledge translation 5-item MCQ 1,2,3,4,5,6,8 Secondary outcome Cognitive Engagement One week Knowledge retention 5-item MCQ 2,3,4,5,6,7 Secondary outcome, maintenance End of study Knowledge retention 30-item MCQ 0, 8 Secondary outcome, maintenance Affective engagement YouTube Like/Dislike 1,2,3,4,5,6 Secondary outcome Intervention adherence / Behavioral Engagement Watch Time YouTube watch time % 1,2,3,4,5,6 Primary outcome, adoption, implementation Viewings YouTube # views 1,2,3,4,5,6 Primary outcome, adoption, implementation Number recruited, rejected, randomized, dropped off, completed Number 0,1,2,3,4,5,6,7,8 Primary outcome, implementation Dropout reasons Participant response 1,2,3,4,5,6,7,8 Primary outcome, implementation Outcomes completed % 8 Primary outcome, implementation Adverse events Number and type 1,2,3,4,5,6,8 Primary outcome, effectiveness Satisfaction with care and treatment Tailored question 8 Primary outcome, effectiveness Abbreviations: SRS-22r, Scoliosis Research Society 22-revised; EQ-5D-Y, EuroQOL 5 Dimension Youth version; PAQ-C, Physical Activity Questionnaire for Children;

STAI-Ch, State Trait Anxiety Index for Children; MCQ, Multiple Choice Questionnaire. https://doi.org/10.1371/journal.pone.0297394.t001 PLOS ONE Multimedia education materials for adolescent idiopathic scoliosis PLOS ONE | https://doi.org/10.1371/journal.pone.0297394 May 23, 2024 4 / 14